CAR-T细胞治疗产品体外效力的检测策略与技术进展  

Review of in vitro potenc assays for CAR-T cell therapy products

作　　者：王自强 王灿 厉高慜 段徐华 邵泓 WANG Zi-qiang;WANG Can;LI Gao-min;DUAN Xu-hua;SHAO Hong(Shanghai Institute for Food and Drug Control/National Medical Products Administration Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies/Shanghai Quality Inspection and Testing Center for Innovative Biological Products,Shanghai 201203,China)

机构地区：[1]上海市食品药品检验研究院/国家药品监督管理局治疗类单抗质量控制重点实验室/上海市创新生物质品质量检验检测中心,上海201203

出　　处：《中国新药杂志》2023年第18期1837-1842,共6页Chinese Journal of New Drugs

摘　　要：随着嵌合抗原受体T细胞(chimeric antigen receptor T cell, CAR-T)等细胞治疗产品的应用走向成熟,其产品质量的检测方法也日渐受到关注。体外活力是评价细胞治疗产品有效性的重要方法,体外效力测定方法也以其简单、快速的特点,在产品放行过程中被广泛采用。本文从效应细胞及靶细胞这2个角度对CAR-T等细胞治疗产品体外效力测定方法进行综述。As the use of cell therapy products such as chimeric antigen receptor T cells(CAR-T)is getting matured,there has been an increasing interest in the methods used to test the quality of cell therapy products.In vitro viability assay is an important method for evaluating the effectiveness of cell therapy products and is also widely used in the product release process because of its simplicity and rapidity.In this paper,we review the in vitro potency determination methods for cell therapy products such as CAR-T from the perspective of both effector cells and target cells.

关 键 词：CAR-T细胞 效力测定 质量控制 细胞杀伤 细胞因子分泌 

分 类 号：R972.6[医药卫生—药品]